Bio­gen qui­et­ly whisks away its $544M au­toim­mune ri­val to Cel­gene

Al San­drock, Bio­gen

Bio­gen is sup­posed to be hunt­ing up new deals to fat­ten its late-stage pipeline. In­stead, the com­pa­ny used its quar­ter­ly num­bers re­view to­day to whisk one of its pro­grams out the back door with as lit­tle com­ment as pos­si­ble.

At the end of a ros­ter of pos­i­tive events in Q3, the big biotech not­ed: Bio­gen has dis­con­tin­ued de­vel­op­ment of amise­limod (MT-1303), which tar­gets the sphin­go­sine 1-phos­phate (S1P) re­cep­tor.

That’s the same mech­a­nism that dri­ves Cel­gene’s ozan­i­mod, ac­quired in the $7.2 bil­lion Re­cep­tos buy­out, which it has tapped as a top prospect in the pipeline.

We’ll have to wait for more of an ex­pla­na­tion for the sud­den about-face from Bio­gen dur­ing the call.

Bio­gen was much more vo­cal when it bagged the world­wide (ex-Asia) li­cense for amise­limod (MT-1303) a lit­tle more than a year ago. The com­pa­ny paid Mit­subishi Tan­abe $60 mil­lion up front and promised $484 mil­lion in mile­stones — which now go poof.

Com­pa­ny CMO Al San­drock high­light­ed this drug in an in­ter­view I had with him at the lat­est JP Mor­gan gath­er­ing. At the time, Bio­gen was look­ing at putting the Phase III-ready au­toim­mune drug through a rapid late-stage de­vel­op­ment plan for mul­ti­ple scle­ro­sis, but what­ev­er it found out about the drug in the mean­time must have chilled their en­thu­si­asm.

As Jef­feries not­ed, Bio­gen is still very en­thu­si­as­tic about its Alzheimer’s drug ad­u­canum­ab, which is in a high-risk field. And the firm — which pegged ‘1303 as a po­ten­tial block­buster — al­so re­cent­ly high­light­ed Bio­gen’s sec­ond thoughts on the drug just days ago.

Ph.II Crohn’s da­ta is still pos­si­ble by year-end as well as a ph.III start in IBD, though our sense was that BI­IB is close­ly ex­am­in­ing the evolv­ing com­pet­i­tive land­scape to de­ter­mine po­ten­tial next steps. (cur­rent­ly mod­el $1B prob-ad­just­ed out-year revs). We be­lieve this is pru­dent giv­en the lead time oth­er drugs have over ‘1303.

Bio­gen has had its ups and downs this year, but it’s failed to de­liv­er on cre­at­ing the kind of pipeline need­ed to main­tain faith in its fu­ture — par­tic­u­lar­ly as Tec­fidera sales fade and new ri­vals loom for that key mar­ket. CEO George Scan­gos is on the way out and an­a­lysts are still wait­ing to see how the com­pa­ny will po­si­tion it­self for 2017.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment

While many others have tried — and failed — to get a NASH candidate across the finish line, Terns Pharmaceuticals thinks its FXR agonist will eventually earn its wings without the safety issues that have slowed others down. Now, a mid-stage safety readout could help add some validity to those hopes.

No patients in the Phase IIa LIFT study discontinued TERN-101 due to side effects, CMO Erin Quirk said during a call with investors on Monday morning. That includes pruritus, an uncomfortable itching sensation that frequently leads patients to drop out of other FXR agonist studies.

Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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